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Credits
Devices
Name
Classification
Manufacturer
Risk Class
Country
Source
Bulk Loader Module for cobas p 512/612
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Blood Gas and Electrolytes Analyzer
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
ACCUCHEK
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
COBAS INTEGRA 800 Analyzer
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall ACCUCHEK Tender II Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall ACCUCHEK Tender I Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall ACCUCHEK Tender I Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall ACCUCHEK Tender I Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall ACCUCHEK Tender I Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall ACCUCHEK Tender I Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall ACCUCHEK Tender I Infusion Set
General Hospital and Personal Use Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall Roche cobas IT 1000
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche cobas e 602 module
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Roche cobas e 601 module
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Modular Analytics
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Cobas c8000 Modular Analyzer Series Cobasc502
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall Omni Microelectrode for cobas b221 analyzer
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
United States
Device Recall MagNA Pure 96 System
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall ACCUCHECK FastClix
General and Plastic Surgery Devices
Roche Diagnostics Operations, Inc.
1
United States
Device Recall CoaguChek XS System (HCP)
Hematology and Pathology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall CoaguChek XS Plus System
Hematology and Pathology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall CoaguChek XS Pro System
Hematology and Pathology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall CoaguChek XS System (PST)
Hematology and Pathology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall CoaguChek XS Pro meters
Hematology and Pathology Devices
Roche Diagnostics Operations, Inc.
2
United States
Device Recall AccuCheK Inform II Blood Glucose Monitor
Clinical Chemistry and Clinical Toxicology Devices
Roche Diagnostics Operations, Inc.
2
United States
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